SigmaPharm Laboratories LLC is recalling approximately 1,993 bottles of Sodium Phenylbutyrate powder (250 grams) used to treat certain urea cycle disorders. Routine testing revealed that the medication contained impurities that were outside of the required safety specifications. This recall affects various lots with expiration dates ranging from May 2023 to May 2024 that were distributed nationwide throughout the United States.
The presence of impurities at levels exceeding approved specifications may alter the safety and effectiveness of the medication, potentially leading to unforeseen side effects or reduced treatment efficacy for patients with urea cycle disorders.
Healthcare provider consultation and pharmacy refund
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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